15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MBI ILLUMINATED RETINAL PICK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOCLONES ELEGANCE FSH ELISA KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MANAN CONTRAST MEDIA ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
HCL LABORATORY SYSTEMS 200 -LISA-
FDA Adverse Event
Other
·HYCEL DIAGNOSTICS·Product code JJF·November 8, 2000
EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE¿
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·October 3, 2025
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
UNSPECIFIED CENTRAL LINE CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·July 8, 2025
ESTEEM
FDA Adverse Event
Malfunction
·ENVOY MEDICAL·Product code OAF·June 19, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MPRI·Product code NVN·February 15, 2013
UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code MMI·January 19, 2011
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012